Wayne Malone

Five Medical Device Commercialization Tips to Enable Success

Medical Device Commercialization TipsCommercialization of a medical device is the process of transitioning from design and development to a realized, manufacturable, and sellable product.
This blog describes how our commercialization team “Make it Real” by developing robust commercialization strategies that engage a cross-functional team from engineering, production planning and supply chain.

Continue reading »

Vanessa Del Castillo Faria

How to Build a Strategic Medical Device Supply Chain

NPI Strategic Supply ChainMedical Device Supply Chain strategies have been evolving since the 1990s. It started with the famous “Pick two from: better, faster, or cheaper”. You could not have all three…
Then in the 2000s with the rapid expansion of high-tech companies, the medical device supply chain strategy umbrella expanded to include better, now, cheaper, agile, global, different, custom, green, lean and so on. With so many variants it was difficult to prioritize.

Continue reading »

Astero StarFish

Tips for Better Medical Device Product Definition

Medical Device Product DefinitionThe medical device product definition process can make or break a novel medical device. Our experts discussed the topic and offered tips in a recent medical device product definition roundtable. Their tips range from general guidelines to regulatory, reimbursement, lean startups, architecture, and hazard management.

Continue reading »


ALARP to AFAP, the MDR and ISO 14971:2019+A11:2021

Medical Device Risk ManagementThe risk management approach

ALARP (As Low As Reasonably Practicable) to AFAP (As Far As Possible) and medical device risk management has always been a tricky one. The nature of the products, their intended use, and the markets in which they are sold influences the approaches in controlling risk. When it comes to risk, the first thing to consider is the ISO 14971 standard. MDR and IVDR changes bring a new alignment in terms of risk.

Continue reading »

Lorenzo Gutierrez

Cancer detection technologies on microfluidic chips

Cancer Detection Microfluidic TechnologiesWhen you hear the word cancer, it conjures up sad feelings. Most patients think that if they have it, they have less chance to survive and it’s the start of a countdown to death. Most people only know of the most common treatments such as – chemotherapy, which uses drugs to kill cancer cells, radiation which is used to destroy cancer cells and damage cancer cell’s DNA to stop dividing and growing, and surgery which remove the cancer tissues. They imagine losing hair and being in the hospital for weeks or even, months. But what is cancer, really? Is there a cure? What’s the chance of survival?

Continue reading »

Emily Hayhurst

How to get the most out of medical device user testing

Medical Device User Testing Do you know the most overlooked step in creating a useful medical device?

It might sound surprising, but if we were to look at a graveyard of failed products, more often than not they fail because, while they deliver their promise, they fail the user. Do not underestimate how critical it is to seek user feedback in the design process. User feedback is essential for making educated design decisions.

Continue reading »

Nadia Routhier

Cardboard Mock-Ups Vs. 3D Printing for Rapid Iterations

Rapid Prototyping Human FactorsWhen I joined StarFish Medical I was pretty stoked about the 3D printer and marvelled at the prints created by the Mechanical Engineers and Industrial Designers. As a Human Factors Engineer in product development my favorite challenges are the ones that call on imaginative solutions for investigating and testing use-related ideas and concepts for new products.

Continue reading »

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks